MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHACTIVE IMPLANT; DENTAL IMPLANT

Catalog Number	944108
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted and explanted dates are unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per (b)(4), during clinical procedure, patient experienced lack of primary stability.
Additional Manufacturer Narrative
Re-evaluation for reportability concludes that this event is not likely to cause or contribute to death, serious injury, or serious deterioration in health.Therefore, this complaint is non-reportable to the fda.Updated section b4 for report submission date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type.

• Brand Name: SWISHACTIVE IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 12083825
• Report Number: 3001617766-2021-03828
• Device Sequence Number: 14319077
• Product Code: DZE
• UDI-Device Identifier: 10841307106654
• UDI-Public: 10841307106654
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2024
• Device Catalogue Number: 944108
• Device Lot Number: 148371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 59